Label: STOMACH RELIEF REGULAR STRENGTH- bismuth subsalicylate liquid
- NDC Code(s): 55315-372-08
- Packager: Freds Inc
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated November 28, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each 30 mL)
- Purpose
- Uses
-
Warnings
Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms ahould not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.
Allergy alert: Contains salicylate. Do not take if you are
- allergic to salicylates (including aspirin)
- taking other salicylate products
Ask a doctor or pharmacist before use if you are
taking any drug for
- diabetes
- gout
- arthritis
- anticoagulation (thinning the blood)
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Directions
- shake well before using
- mL = milliliter
- measure only with dosing cup provided. Do not use any other dosing device
- keep dosing cup with product
- adults and children 12 years and over
- 30 mL(1 dose) every 1/2 to 1 hour as needed
- do not exceed 8 doses (240 mL) in 24 hours
- use until diarrhea stops but not more than 2 days
- children under 12 years of age: ask a doctor
- drink plenty of clear fluids to help prevent dehydration caused by diarrhea
- Other information
- Inactive ingredients
- Questions or comments?
-
Principal Display Panel
Compare to the Active Ingredient in Pepto-Bismol®*
Stomach Relief
Bismuth subsalicylate 525 mg
Upset Stomach Reliever / Antidiarrheal
REGULAR STRENGTH
Relieves Upset Stomach, Heartburn, Indigestion, Nausea, Diarrhea
Alcohol Free
Sugar Free
FL OZ (mL)
*This product is not manufactured or distributed by The Procter & Gamble Company. Pepto-Bismol® is a registered trademark of The Procter & Gamble Company.
TAMPER EVIDENT; DO NOT USE IF PRINTED SAFETY SEAL UNDER AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
DISTRIBUTED BY: fred's Inc.
4300 NEW GETWELL RD, MEMPHIS, TN 38118
- Package Label
-
INGREDIENTS AND APPEARANCE
STOMACH RELIEF REGULAR STRENGTH
bismuth subsalicylate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55315-372 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BISMUTH SUBSALICYLATE (UNII: 62TEY51RR1) (BISMUTH CATION - UNII:ZS9CD1I8YE, SALICYLIC ACID - UNII:O414PZ4LPZ) BISMUTH SUBSALICYLATE 525 mg in 30 mL Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) D&C RED NO. 22 (UNII: 1678RKX8RT) D&C RED NO. 28 (UNII: 767IP0Y5NH) MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SALICYLIC ACID (UNII: O414PZ4LPZ) SODIUM SALICYLATE (UNII: WIQ1H85SYP) SORBIC ACID (UNII: X045WJ989B) METHYLCELLULOSE (1500 CPS) (UNII: P0NTE48364) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55315-372-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 03/31/2015 06/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M008 03/31/2015 06/30/2024 Labeler - Freds Inc (005866116)